(0)

DIA会员及用户请点击登录

登录

忘记用户 ID？ or 忘记密码？

Not a Member?

创建账户并加入。

Sheraton Boston Hotel

2017 年 08 月 16 日 8:00 上午 - 2017 年 08 月 17 日 5:15 下午

39 Dalton Street, , Boston, MA 02119 , USA

European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations

概览

This intermediate course provides description and discussion of the complete spectrum of necessary regulatory procedures: marketing authorization registration procedures, variation procedures, renewal procedures and more. An expert instructor will use practical examples and experiences to illustrate procedures. The course focuses on Europe, but also reviews regulations in other regions including the US and Japan.

内容纲要

  • Drug Regulations
  • Role of Regulatory Affairs in Drug Development / Approval / Marketing
  • Registration Dossier
  • Regulatory Strategy
  • Variations: The Role of Regulatory Affairs after Marketing Authorization
  • Transparency in Drug Regulatory Affairs

谁应该参加？

This course provides the knowledge and tools for experts and managers from the regulatory agencies and pharmaceutical industry working in the areas of:

  • Regulatory Affairs
  • Clinical drug development
  • Preclinical drug development
  • Pharmaceutical development
  • Manufacturing
  • Drug quality control
  • Quality assurance and compliance
  • Regulatory writing
  • Drug import /export

学习目标

At the conclusion of this course, participants should be able to:

  • Define the drug legislation and regulation with a focus on the EU
  • Demonstrate successful knowledge of the Internet to locate relevant documents
  • Identify the key functions of regulatory affairs during the different phases of a drug life cycle
  • Formulate successful regulatory strategies and apply it to the product concerned

Digital Learning Catalog

DIA Learning: eLearning Soultions
Download

获得信息并保持参与

不要错失任何机会——请加入我们的邮件列表，了解DIA的观点和事件。